GADOVIST 1MMOL/ML PREFILLED SYRINGE 5.0 ML [SIN13807P]

Product Info

GADOVIST 1MMOL/ML PREFILLED SYRINGE 5.0 ML

[SIN13807P]

4.1 Indications

This medicinal product is for diagnostic use only.

Gadovist is indicated in adults and children of all ages including full-term newborns:

• Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI).

• Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.

• Contrast enhancement in Magnetic Resonance Angiography (CE-MRA).

Gadovist can also be used for MR Imaging of pathologies of the whole body. It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue.

4.2 Dosage and method of administration

4.2.1 Method of administration

The dose required is administered intravenously as a bolus injection.

For additional instructions see section ‘Instructions for use/handling’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contrast-enhanced MRI can commence immediately afterwards (shortly after the injection depending on the pulse sequences used and the protocol for the examination). Optimal signal enhancement is observed during arterial first pass for CE-MRA and within a period of about 15 minutes after injection of Gadovist for other indications (time depending on type of lesion/tissue).

T₁-weighted scanning sequences are particularly suitable for contrast-enhanced examinations.

The usual safety rules for magnetic resonance imaging must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants.

Nausea and vomiting are known adverse reactions associated with administration of contrast media. The patient should therefore refrain from eating for two hours prior to investigation in order to minimize risk of vomiting and possible aspiration.

4.2.2 Dosage
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.

Adults:
Dosage depends on indication. A single intravenous injection of 0.1 mmol gadobutrol per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) is generally sufficient. A total amount of 0.3 mmol gadobutrol per kg body weight (equivalent to 0.3 ml gadobutrol per kg body weight) may be administered at maximum.

• Whole body MRI (except MRA)

  In general, the administration of 0.1ml Gadovist per kg body weight is sufficient to answer the clinical question.

  • Additional dosage recommendation for cranial and spinal MRI

    If a strong clinical suspicion of a lesion persists despite a normal contrast-enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, a further injection of 0.1 ml Gadovist per kg body weight up to 0.2 ml Gadovist per kg body weight of the 1.0 mmol/ml solution Gadovist within 30 minutes of the first injection may increase the diagnostic yield of the examination.

    For the exclusion of metastases or recurrent tumours the injection of 0.3 ml Gadovist per kg body weight often leads to higher diagnostic confidence. This applies to lesions with poor vascularization and/or small extracellular space or when relatively less heavily T₁-weighted scanning sequences are used.

    For brain perfusion studies, the use of an injector is recommended: 0.3 ml Gadovist per kg body weight (3 – 5 ml/sec).

• CE-MRA

  Imaging of one field of view:
  7.5ml for body weight less than 75kg
  10ml for body weight of 75kg or more
  (corresponding to 0.1–0.15 mmol per kg body weight)

  Imaging of more than one field of view:
  15ml for body weight less than 75 kg
  20ml for body weight of 75kg or more
  (corresponding to 0.2–0.3 mmol per kg body weight)

4.2.3 Special patient populations

4.2.3.1 Pediatric patients

For children of all ages including full-term newborns, the recommended dose is 0.1 mmol gadobutrol per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) for all indications, see section ‘Indications’.

Neonates up to 4 weeks of age and infants up to 1 year of age

Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful consideration at a dose not exceeding 0.1mmol/kg body weight; More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadovist injections should not be repeated unless the interval between injections is at least 7 days.

4.2.3.2 Elderly (aged 65 years and above)

In clinical studies, no overall differences in safety or effectiveness were observed between elderly (aged 65 year and above) and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is considered necessary. Caution should be exercised in elderly patient (see section ‘Special warnings and precautions for use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.3.3 Patients with hepatic impairment

Since Gadobutrol is exclusively eliminated in an unchanged form via the kidneys, no dosage adjustment is considered necessary (see also section ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.3.4 Patients with renal impairment

The elimination of gadobutrol is prolonged in patients with renal impairment. In patients with severely impaired renal function the benefits must be weighed carefully against the risks. However, to ensure diagnostically useful images no dosage adjustment is recommended (see also section “Special warnings and precautions for use” and section “Pharmacokinetics properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Gadobutrol is renally excreted; sufficient period of time for elimination of the contrast agent from the body prior to any re-administration in patients with renal impairment should be ensured. Usually, complete recovery in the urine was seen in patients with mild or moderate renal impairment within 72 hours. In patients with severely impaired renal function at least 80 % of the administered dose was recovered in the urine within 5 days (see also section ‘Special warnings and precautions for use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Gadovist should only be used in patients with severe renal impairment (GFR < 30ml/min/1.73m²) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.

If it is necessary to use Gadovist, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadovist injections should not be repeated unless the interval between injections is at least 7 days.

4.3 Contraindications

Hypersensitivity to any of the ingredients.